Alatrofloxacin Injection (patient information)

IMPORTANT WARNING

Alatrofloxacin injection is no longer available in the U.S. If you are currently taking alatrofloxacin injection you should call your doctor to discuss switching to another treatment.

Alatrofloxacin has been associated with serious liver injury leading to liver transplantation or death. Alatrofloxacin-associated liver injury has been reported with both short- and long-term drug exposure. Alatrofloxacin use exceeding 2 weeks in duration is associated with a significantly increased risk of serious liver injury. Liver injury has also been reported following alatrofloxacin re-exposure. Alatrofloxacin should be reserved for use in patients with serious, life- or limb-threatening infections who receive their initial therapy in an in-patient health care facility (i.e., hospital or long-term nursing care facility). Alatrofloxacin should not be used when safer, alternative antimicrobial therapy will be effective.

If you experience any of the following symptoms, call your doctor immediately: increased fatigue, loss of appetite, yellowing of the skin and eyes, severe stomach pain with nausea and vomiting, or dark urine. Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your response to alatrofloxacin.

About your treatment

Your doctor has ordered alatrofloxacin, an antibiotic, to help treat your infection. The drug will be added to an intravenous fluid that will drip through a needle or catheter placed in your vein for 60 minutes or more, once a day.

Alatrofloxacin eliminates bacteria that cause many kinds of infections, including pneumonia and skin, urinary, respiratory, sinus, gynecological, sexually transmitted, and gastrointestinal tract infections. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Your health care provider (doctor, nurse, or pharmacist) may measure the effectiveness and side effects of your treatment using laboratory tests and physical examinations. It is important to keep all appointments with your doctor and the laboratory. The length of treatment depends on how your infection and symptoms respond to the medication.

Precautions

Before administering alatrofloxacin:

• tell your doctor and pharmacist if you are allergic to alatrofloxacin, cinoxacin (Cinobac), ciprofloxacin (Cipro), enoxacin (Penetrex), erythromycin, levofloxacin (Levaquin), lomefloxacin (Maxaquin), nalidixic acid (NegGram), norfloxacin (Noroxin), ofloxacin (Floxin), sparfloxacin (Zagam), trovafloxacin (Trovan), or any other drugs.
• tell your doctor and pharmacist what prescription and nonprescription medications you are taking, especially other antibiotics, anticoagulants ('blood thinners') such as warfarin (Coumadin), cyclosporine (Neoral, Sandimmune), medications containing caffeine (NoDoz, Vivarin), probenecid (Benemid), theophylline (Theo-Dur), and vitamins.
• tell your doctor if you have or have ever had liver or kidney disease, epilepsy, or any other neurological disorder.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking alatrofloxacin, call your doctor immediately.
• you should know that this drug may make you drowsy. Do not drive a car or operate machinery until you know how this drug will affect you.
• plan to avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing, sunglasses, and sunscreen. Alatrofloxacin may make your skin sensitive to sunlight.

Administering your medication

Before you administer alatrofloxacin, look at the solution closely. It should be clear and free of floating material. Gently squeeze the bag or observe the solution container to make sure there are no leaks. Do not use the solution if it is discolored, if it contains particles, or if the bag or container leaks. Use a new solution, but show the damaged one to your health care provider.

It is important that you use your medication exactly as directed. Do not stop your therapy on your own for any reason because your infection could worsen and result in hospitalization. Do not change your dosing schedule without talking to your health care provider. Your health care provider may tell you to stop your infusion if you have a mechanical problem (such as blockage in the tubing, needle, or catheter); if you have to stop an infusion, call your health care provider immediately so your therapy can continue.

Side effects

Minor Side Effects

Alatrofloxacin may cause side effects. Tell your health care provider if any of these symptoms are severe or do not go away:

• dizziness
• lightheadedness
• headache
• drowsiness
• upset stomach
• vomiting
• diarrhea

Severe Side Effects

If you experience any of the following symptoms, or those listed in the IMPORTANT WARNINGS section, call your doctor immediately:

• skin rashes
• hives
• itching
• sunburn
• swelling of the face or throat
• difficulty breathing or swallowing
• depression
• hallucinations
• seizures or convulsions
• change in vision
• vaginal infection
• pain, inflammation, or rupture of a tendon

Storing your medication

Your health care provider may give you a several-day supply of alatrofloxacin at a time. You will be told to store it in the refrigerator. Take your next dose from the refrigerator 1 hour before using it; place it in a clean, dry area to allow it to warm to room temperature. Store your medication only as directed. Make sure you understand what you need to store your medication properly. Keep your supplies in a clean, dry place when you are not using them, and keep all medications and supplies out of reach of children. Your health care provider will tell you how to throw away used needles, syringes, tubing, and containers to avoid accidental injury..

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Signs of infection

You should be aware of the symptoms of infection in case your infection worsens or a new infection develops. If you notice any of the following symptoms, tell your health care provider as soon as possible:

• fever
• unusual tiredness or weakness
• chills
• shaking
• nighttime sweating
• loss of appetite

If you are receiving alatrofloxacin in your vein or under your skin, you need to know the symptoms of a catheter-related infection (an infection where the needle enters your vein or skin). If you experience any of these effects near your intravenous catheter, tell your health care provider as soon as possible:

• tenderness
• warmth
• irritation
• drainage
• redness
• swelling
• pain

Brand names

• Trovan Injection®